**Source URL:** https://safety.veevavault.help/en/lr/1299973/

# Create Frequency Analysis Reports

In addition to standard regulatory aggregate reports, Safety also provides a frequency analysis report to help identify adverse event trends across large case volumes and customizable timeframes.
Vault generates the following frequency analysis tabulations by default, each providing support for masking:

* [Summary Tabulation of Events by Period and Product][101]
* [Summary Tabulation of Events by Expectedness and Product][102]
* [Summary Tabulation of Events by Case Category and Product][103]
* [Summary Tabulation of Events by Seriousness and Product][104]
* [Summary Tabulation of Events by Relatedness and Product][105]
* [Interval Line Listing of Events][106]

## Prerequisites

To generate frequency analysis tabulations and lines:

* You must be assigned permissions to view and prepare aggregate reports. Typically, these permissions are reserved for the Safety Writer and Head of Safety roles.
* The Reporting Family must contain the _Products_, _Studies_, and _Substances_ to include in the _Frequency Analysis_ report.
* To add a tab at the beginning of the aggregate report document detailing the criteria used to generate the report, your Admin must enable the  Criteria Page for Aggregate Reports.
* To use custom report templates, your Admin must configure report templates for each applicable _Frequency Analysis_ report.

## Create a Frequency Analysis Report {#create}

To create a _Frequency Analysis_ report:

1. Navigate to **Aggregate Reports > Frequency Analysis**.
2. Select **Create**.
3. Complete the applicable [fields][2].
4. Select **Save**.

The _Frequency Analysis_ report enters the _Pending_ state. Vault assigns a task to users in the Safety Writer role to [review the report details][3].

### Frequency Analysis Report Fields {#fields}

The following fields may be available:

<table>
<thead>
<tr>
<th>Field
<th>Description

<tbody>
<tr>
<td markdown="span">_Product Family_
<td markdown="block">

Select the _Reporting Family_ of type _Product Family_ configured for aggregate reporting. The _Reporting Family_ defines the _Cases_ Vault includes in the report, considering all _Cases_ with:

* A _Product_ in the _Reporting Family_
* A _Study_ in the _Reporting Family_
* A blinded _Study_ for a _Product_ in the _Reporting Family_

<tr>
<td markdown="span">_Organization_
<td markdown="block">

Vault populates the _Organization_ on the selected _Reporting Family_.

<tr>
<td markdown="span">_Filter Case By_
<td markdown="block">

To customize how Vault filters _Cases_ within the specified date range, select an option:

* __Case Receipt Date / New Info Date__: Vault filters cases by the latest date when the source provided information, from the most recent available date in the _Receipt Date_ and _New Info Date_ fields.
* __Case Approval Date__: Vault filters cases by the date when the _Case_ moved into the _Approved_ state. If the _Case_ was revised for a non-significant follow-up, the most recent approval date is used.

If this field is blank, Vault uses the _Case Receipt Date/New Info Date_.

<tr>
<td markdown="span">_Filter by Country_
<td markdown="block">

Select one or more countries to restrict report data to specific health authorities. Leave blank to include _Cases_ from all countries. If populated, Vault includes _Cases_ where at least one of the following matches your selections:

* The _Event Country_ of a _Case Adverse Event_
* The _Reporter Country_ of the _Case_

<tr>
<td markdown="span">_Data Period Start_
<td markdown="block">

Enter the data period start date of [Period 1][3].

<tr>
<td markdown="span">_Data Period End_
<td markdown="block">

Enter the data period end date of [Period 1][3].

<tr>
<td markdown="span">_States to Include_
<td markdown="block">

Select the states that _Cases_ must be in to be included in the report.

Vault [excludes][5] _Cases_ in the _Nullified_ or _Voided_ state.

<tr>
<td markdown="span">_Seriousness_
<td markdown="block">

Select one or more _Seriousness_ values to filter the _Case Adverse Events_ included in the report.

Vault excludes _Cases_ related to _Case Adverse Events_ that do not match your selection, even if another event on the same _Case_ matches.

<tr>
<td markdown="span">_Include Invalid Cases_
<td markdown="block">

Select this checkbox to include _Cases_ in the _Invalid_ lifecycle state, or that have the _Invalid Reason_ field populated, regardless of whether the _Case_ is suppressed.

If you do not select this checkbox, Vault excludes invalid _Cases_, as well as valid _Cases_ that are suppressed.

<tr>
<td markdown="span">_Drug Roles to Include_
<td markdown="block">

Select one or more _Drug Roles_ to include in the report.

<tr>
<td markdown="span">_Generate Masked Documents_
<td markdown="block">

Select this option to generate a masked copy of the _Frequency Analysis_ report document, in addition to the unmasked copy, when at least one blinded _Study_ is associated with the _Reporting Family_.

On a masked tabulation, Vault adds an additional __Blinded__ product row that counts events on blinded _Cases_ and _Products_. On a masked line listing, Vault displays _Blinded_ for the Product Name on blinded Study Products, regardless of whether the individual _Case_ is blinded or unblinded.

To learn more, see Generate Masked Aggregate Tabulations (CIOMS II, PBRER and DSUR).

<tr>
<td markdown="span">_Include Criteria Page on Documents_
<td markdown="block">

Select the checkbox to add a tab at the beginning of the generated report file detailing the filters used to generate the report, including the dates specified for each configured reporting period. If the report masks blinded information, the criteria page also indicates which details are blinded.

### Reporting Periods {#reporting-periods}

Vault generates up to three _Aggregate Report Intervals_ associated with the _Frequency Analysis_ report. Each _Aggregate Report Interval_ has an _Interval Start Date_ and _Interval End Date_ which define the date range for that period.

* **Period 1**: Vault uses the *Data Period Start* and *Data Period End* values on the *Frequency Analysis* report to populate the *Interval Start Date* and *Interval End Date* on the *Interval 1* record in the *Aggregate Report Intervals* section. Vault keeps these values in sync: updating the *Data Period Start* or *Data Period End* on the *Frequency Analysis* report updates the *Interval Start Date* or *Interval End Date* on *Interval 1*, and updating the *Interval Start Date* or *Interval End Date* on *Interval 1* updates the *Data Period Start* or *Data Period End* on the *Frequency Analysis* report.
* **Period 2 and Period 3**: After you save the *Frequency Analysis* report, Vault adds blank *Interval 2* and *Interval 3* records to the report's *Aggregate Report Intervals* section. Populate their *Interval Start Date* and *Interval End Date* fields to activate Period 2 and Period 3 on the report.

Vault displays Period columns only for the *Aggregate Report Intervals* you populate. As such, if you leave *Interval 2* and *Interval 3* blank, Vault omits the Period 2 and Period 3 columns from the report.

## Generate Frequency Analysis Report Tabulations {#generate}

Review and verify the report settings. Once you have confirmed the report details are correct, use the **Generate Aggregate Report Tabulations** action to generate _Frequency Analysis_ report tabulations.

## Frequency Analysis Report Table Generation Data Mapping

Vault populates aggregate report tabulations using _Cases_ within the reporting period specified on the _Frequency Analysis_ report, and the reporting family members configured on the associated _Reporting Family_. In each summary tabulation, Vault sorts rows alphabetically, first by _Product_, then by _MedDRA Preferred Term_ (PT), with grand total rows displayed last. The number of _Period_ columns shown on a tabulation matches the number of [reporting intervals][3] configured on the _Frequency Analysis_ report.

**Note**: For blinded _Studies_, Vault populates blinded _Product_ information as `Blinded` in the generated tabulations. If the Blinded Placeholder Name field is populated, Vault populates this name on the report instead of the generic `Blinded` label.

### Inclusion Criteria for Frequency Analysis Reports {#inclusion-criteria}

Vault considers the following criteria when assessing _Cases_ for inclusion in _Frequency Analysis_ reports:

#### Product or Study Product in Reporting Family

A _Case_ must have a _Case Product_ that meets either of the following conditions:

* The _Case Product_ is a member of the _Reporting Family_, or has a _Product Substance_ that is a member of the _Reporting Family_.
    `case_version__vr.case_product__v.product__v IN` 

    `aggregate_report_family__vr.aggregate_report_family_join__vr.products__v` 

* The _Case Product_ has a _Product Substance_ that is a member of the _Reporting Family_.
    `reporting_family_v.substance__v.substance_v ≠ BLANK` 

    `AND reporting_family_v.substance__v.substance_v =` 

    `case_product__v.product__v.product_substance__v`

If the _Frequency Analysis_ report incorrectly includes a _Case_ due to the _Product_ or _Study_ changing between _Case_ versions, your Admin can enable the _Consider Reporting Family after Latest Version_ feature so that Vault applies the _Reporting Family_ filter after determining the latest _Case_ version. Enabling this feature has a performance impact.

If required, your Admin can enable the _Consider Reporting Family after Latest Version_ feature which controls whether the _Reporting Family_ filter is applied before or after determining the latest _Case_ version. Enabling this feature impacts report performance.

**Note**: Vault applies the same blinded and unblinded _Study Product_ handling used for PBRER reports when determining _Reporting Family_ membership.

#### Country Filter

If the _Frequency Analysis_ report contains one or more values in the _Filter by Country_ field, Vault includes _Cases_ for each _Country_ that matches at least one of the following criteria:
* An _Event Country_ on any related _Case Adverse Event_
* The _Reporter Country_ on the _Case_

If the _Filter by Country_ field is blank, Vault includes _Cases_ for all _Countries_.

#### Seriousness Filter

Vault filters individual _Case Adverse Events_ by the _Seriousness_ value selected on the report.

#### Case Data in Cumulative Reporting Period

The date must be within the _Frequency Analysis_ report cumulative reporting period. How Aggregate Reports Filter by Data Period provides more information.

`DATE ≤ dsur__v.data_period_end__v`

where _DATE_ depends on the option selected in the [_Filter Case By_][6] (`dsur__v.filter_cases_by__v`) field:

* When blank or _Case Receipt Date / New Info Date_ (Default):
  * If the _Case_ _New Info Date_ (`new_info_date__v`) is blank, Vault uses the _Receipt Date_: `case_version__v.receipt_date__v`
  * Otherwise, Vault uses the _New Info Date_: `case_version__v.new_info_date__v`
* When _Case Approval Date_: `case_version__v.approval_date__v`

If the _Case_ has multiple versions within the reporting period, Vault lists only the most recent _Case_ version within the reporting period.

#### Case Lifecycle State in Aggregate States to Include

The latest _Case_ version within the reporting period must be in a state specified in the _States to Include_ field on the _Frequency Analysis_ report.

`case_version__v.state__v CONTAINS dsur__v.states_to_include__v`

Vault omits _Cases_ in the following states:
  * _Nullified_ (`nullified_state__v`)
  * _Voided_ (`voided_state__v`)

**Note**: You cannot select these states in the _States to Include_ field. These states are always omitted.

#### Invalid Cases Filter

If _Include Invalid Cases_ is selected (the default), Vault includes _Cases_ with the following:

* A lifecycle state of _Invalid_
* An _Invalid Reason_ value
* A _Suppress Submission_ of _Yes_

#### Case Product in Drug Roles to Include

Vault includes _Case Products_ where the _Drug Role_ matches one of the Drug Roles specified on the _Drug Roles to Include_ field on the _Frequency Analysis_ report.

`case_product__v.drug_role__v CONTAINS frequency_analysis__v.drug_roles_to_include__v`

### Summary Tabulation of Events by Period and Product {#summary-tab-events-period-product}

#### Table Mapping

| Number | Name | Description |
| --- | --- | --- |
| 1 | Product | The _Product_ associated with the _Case Adverse Events_ in the row. If the _Product_ is part of a blinded _Study_ and the report masks blinded information, Vault displays `Blinded` instead of the _Product_ name. |
| 2 | Preferred Term | Vault maps the MedDRA Preferred Term (PT) for the event. If the _PT Aggregation in Periodic Reports_ feature is enabled in your Vault, Vault counts multiple LLTs on the same _Case_ that map to the same PT only once. |
| 3 | Count (Period 1) | Vault totals the number of events for the _Product_ and PT that fall within the dates specified in [_Interval 1_][3]. |
| 4 | % of Grand Total | Vault maps the Count (Period 1) for the _Product_ and PT, divided by the Grand Total. |
| 5 | Count (Period 2) | Vault totals the number of events for the _Product_ and PT that fall within the dates specified in [_Interval 2_][3]. |
| 6 | % of Grand Total | Vault maps the Count (Period 2) for the _Product_ and PT, divided by the Grand Total. |
| 7 | Count (Period 3) | Vault totals the number of events for the _Product_ and PT that fall within the dates specified in [_Interval 3_][3]. |
| 8 | % of Grand Total | Vault maps the Count (Period 3) for the _Product_ and PT, divided by the Grand Total. |
| 9 | Grand Total | Vault maps the total number of events for the _Product_ and PT across all [configured reporting periods][3]. |

### Summary Tabulation of Events by Expectedness and Product {#summary-tab-events-expectedness-product}

#### Table Mapping

| Number | Name | Description |
| --- | --- | --- |
| 1 | Product | The _Product_ associated with the events in the row. If the _Product_ is part of a blinded study and the report masks blinded information, Vault displays `Blinded` instead of the _Product_ name. |
| 2 | Preferred Term | Vault maps the MedDRA Preferred Term (PT) for the event. If the _PT Aggregation in Periodic Reports_ feature is enabled in your Vault, Vault counts multiple LLTs on the same _Case_ that map to the same PT only once. |
| 3 | Period 1 (Expected) | Vault totals the number of _Expected_ events for the _Product_ and PT that fall within the dates specified in _Interval 1_. |
| 4 | Period 2 (Expected) | Vault totals the number of _Expected_ events for the _Product_ and PT that fall within the dates specified in _Interval 2_. |
| 5 | Period 3 (Expected) | Vault totals the number of _Expected_ events for the _Product_ and PT that fall within the dates specified in _Interval 3_. |
| 6 | Total (Expected) | Vault maps the sum of Period 1, Period 2, and Period 3 _Expected_ counts for the _Product_ and PT. |
| 7 | % of Grand Total (Expected) | Vault maps the Total (Expected) for the _Product_ and PT, divided by the Grand Total. |
| 8 | Period 1 (Unexpected) | Vault totals the number of _Unexpected_ events for the _Product_ and PT that fall within the dates specified in _Interval 1_. |
| 9 | Period 2 (Unexpected) | Vault totals the number of _Unexpected_ events for the _Product_ and PT that fall within the dates specified in _Interval 2_. |
| 10 | Period 3 (Unexpected) | Vault totals the number of _Unexpected_ events for the _Product_ and PT that fall within the dates specified in _Interval 3_. |
| 11 | Total (Unexpected) | Vault totals the sum of Period 1, Period 2, and Period 3 _Unexpected_ counts for the _Product_ and PT. |
| 12 | % of Grand Total (Unexpected) | Vault maps the Total (Unexpected) for the _Product_ and PT, divided by the Grand Total. |
| 13 | Grand Total | Vault maps the total number of Expected and Unexpected events for the _Product_ and PT across all configured reporting periods. |

### Summary Tabulation of Events by Case Category and Product {#summary-tab-events-case-category-product}

#### Table Mapping

| Number | Name | Description |
| --- | --- | --- |
| 1 | Product | The _Product_ associated with the events in the row. If the _Product_ is part of a blinded study and the report masks blinded information, Vault displays `Blinded` instead of the _Product_ name. |
| 2 | Preferred Term | Vault maps the MedDRA Preferred Term (PT) for the event. If the _PT Aggregation in Periodic Reports_ feature is enabled in your Vault, Vault counts multiple LLTs on the same _Case_ that map to the same PT only once. |
| 3 | Period 1 (Interventional) | Vault totals the number of _Interventional_ events for the _Product_ and PT that fall within the dates specified in _Interval 1_. |
| 4 | Period 2 (Interventional) | Vault totals the number of _Interventional_ events for the _Product_ and PT that fall within the dates specified in _Interval 2_. |
| 5 | Period 3 (Interventional) | Vault totals the number of _Interventional_ events for the _Product_ and PT that fall within the dates specified in _Interval 3_. |
| 6 | Total (Interventional) | The sum of Period 1, Period 2, and Period 3 _Interventional_ counts for the _Product_ and PT. |
| 7 | % of Grand Total (Interventional) | The Interventional Total for the _Product_ and PT, divided by the Grand Total. |
| 8 | Period 1 (Non-Interventional) | Vault totals the number of _Non-Interventional_ events for the _Product_ and PT that fall within the dates specified in _Interval 1_. |
| 9 | Period 2 (Non-Interventional) | Vault totals the number of _Non-Interventional_ events for the _Product_ and PT that fall within the dates specified in _Interval 2_. |
| 10 | Period 3 (Non-Interventional) | Vault totals the number of _Non-Interventional_ events for the _Product_ and PT that fall within the dates specified in _Interval 3_. |
| 11 | Total (Non-Interventional) | Vault maps the sum of Period 1, Period 2, and Period 3 _Non-Interventional_ counts for the _Product_ and PT. |
| 12 | % of Grand Total (Non-Interventional) | The Non-Interventional Total for the _Product_ and PT, divided by the Grand Total. |
| 13 | Period 1 (Spontaneous) | Vault totals the number of _Spontaneous_ events for the _Product_ and PT that fall within the dates specified in _Interval 1_. |
| 14 | Period 2 (Spontaneous) | Vault totals the number of _Spontaneous_ events for the _Product_ and PT that fall within the dates specified in _Interval 2_. |
| 15 | Period 3 (Spontaneous) | Vault totals the number of _Spontaneous_ events for the _Product_ and PT that fall within the dates specified in _Interval 3_. |
| 16 | Total (Spontaneous) | Vault totals the sum of Period 1, Period 2, and Period 3 _Spontaneous_ counts for the _Product_ and PT. |
| 17 | % of Grand Total (Spontaneous) | Vault maps the Spontaneous Total for the _Product_ and PT, divided by the Grand Total. |
| 18 | Grand Total | Vault maps the total number of Interventional, Non-Interventional, and Spontaneous events for the _Product_ and PT across all configured reporting periods. |

### Summary Tabulation of Events by Seriousness and Product {#summary-tab-events-seriousness-product}

#### Table Mapping

| Number | Name | Description |
| --- | --- | --- |
| 1 | Product | The _Product_ associated with the events in the row. If the _Product_ is part of a blinded study and the report masks blinded information, Vault displays `Blinded` instead of the _Product_ name. |
| 2 | Preferred Term | Vault maps the MedDRA Preferred Term (PT) for the event. If the _PT Aggregation in Periodic Reports_ feature is enabled in your Vault, Vault counts multiple LLTs on the same _Case_ that map to the same PT only once. |
| 3 | Period 1 (Serious) | Vault totals the number of _Serious_ events for the _Product_ and PT that fall within the dates specified in _Interval 1_. |
| 4 | Period 2 (Serious) | Vault totals the number of _Serious_ events for the _Product_ and PT that fall within the dates specified in _Interval 2_. |
| 5 | Period 3 (Serious) | Vault totals the number of _Serious_ events for the _Product_ and PT that fall within the dates specified in _Interval 3_. |
| 6 | Total (Serious) | Vault maps the sum of Period 1, Period 2, and Period 3 _Serious_ counts for the _Product_ and PT. |
| 7 | % of Grand Total (Serious) | Vault maps the Serious Total for the _Product_ and PT, divided by the Grand Total. |
| 8 | Period 1 (Non-Serious) | Vault totals the number of _Non-Serious_ events for the _Product_ and PT that fall within the dates specified in _Interval 1_. |
| 9 | Period 2 (Non-Serious) | Vault totals the number of _Non-Serious_ events for the _Product_ and PT that fall within the dates specified in _Interval 2_. |
| 10 | Period 3 (Non-Serious) | Vault totals the number of _Non-Serious_ events for the _Product_ and PT that fall within the dates specified in _Interval 3_. |
| 11 | Total (Non-Serious) | Vault maps the sum of Period 1, Period 2, and Period 3 _Non-Serious_ counts for the _Product_ and PT. |
| 12 | % of Grand Total (Non-Serious) | Vault maps the Non-Serious Total for the _Product_ and PT, divided by the Grand Total. |
| 13 | Grand Total | Vault maps the total number of Serious and Non-Serious events for the _Product_ and PT across all configured reporting periods. |

### Summary Tabulation of Events by Relatedness and Product {#summary-tab-events-relatedness-product}

#### Table Mapping

| Number | Name | Description |
| --- | --- | --- |
| 1 | Product | The _Product_ associated with the events in the row. If the _Product_ is part of a blinded study and the report masks blinded information, Vault displays `Blinded` instead of the _Product_ name. |
| 2 | Preferred Term | Vault maps the MedDRA Preferred Term (PT) for the event. If the _PT Aggregation in Periodic Reports_ feature is enabled in your Vault, Vault counts multiple LLTs on the same _Case_ that map to the same PT only once. |
| 3 | Period 1 (Related) | Vault totals the number of _Related_ events for the _Product_ and PT that fall within the dates specified in _Interval 1_. |
| 4 | Period 2 (Related) | Vault totals the number of _Related_ events for the _Product_ and PT that fall within the dates specified in _Interval 2_. |
| 5 | Period 3 (Related) | Vault totals the number of _Related_ events for the _Product_ and PT that fall within the dates specified in _Interval 3_. |
| 6 | Total (Related) | Vault maps the sum of Period 1, Period 2, and Period 3 _Related_ counts for the _Product_ and PT. |
| 7 | % of Grand Total (Related) | Vault maps the Related Total for the _Product_ and PT, divided by the Grand Total. |
| 8 | Period 1 (Non-Related) | Vault totals the number of _Non-Related_ events for the _Product_ and PT that fall within the dates specified in _Interval 1_. |
| 9 | Period 2 (Non-Related) | Vault totals the number of _Non-Related_ events for the _Product_ and PT that fall within the dates specified in _Interval 2_. |
| 10 | Period 3 (Non-Related) | Vault totals the number of _Non-Related_ events for the _Product_ and PT that fall within the dates specified in _Interval 3_. |
| 11 | Total (Non-Related) | Vault maps the sum of Period 1, Period 2, and Period 3 _Non-Related_ counts for the _Product_ and PT. |
| 12 | % of Grand Total (Non-Related) | Vault maps the Non-Related Total for the _Product_ and PT, divided by the Grand Total. |
| 13 | Grand Total | Vault maps the total number of Related and Non-Related events for the _Product_ and PT across all configured reporting periods. |

### Interval Line Listing of Events {#interval-line-listing-events}

#### Table Mapping

<table>
<thead>
<tr>
<th>Number
<th>Name
<th>Description

<tbody>

<tr>
<td markdown="span">1
<td markdown="span">Case Name
<td markdown="block">

The _Name_ of the _Case_, displayed as a link to the _Case_ in Vault.

`case_version__v.name__v`

<tr>
<td markdown="span">2
<td markdown="span">Period
<td markdown="block">

The reporting interval (1, 2, or 3) the event falls within, based on the _Interval Start Date_ and _Interval End Date_ configured on the report.

<tr>
<td markdown="span">3
<td markdown="span">Date
<td markdown="block">

The _Case Approval Date_ or the _Case Receipt Date/New Info Date_, depending on the _Filter Case By_ value on the _Frequency Analysis_ report.

If using _Receipt Date/New Info Date_, Vault uses the _New Info Date_ if populated; otherwise, it uses the _Receipt Date_.

`case_version__v.approval_date__v or case_version__v.receipt_date__v / new_info_date__v`

<tr>
<td markdown="span">4
<td markdown="span">Case Category
<td markdown="block">

Vault populates `Spontaneous`, `Interventional`, or `Non-Interventional` based on the _Report Type_, _Study Type_, and _Literature Flag_ values:

`IF case_version__v.report_type__v.e2B_code__v IN ('1','3','4')`

`THEN 'Spontaneous'`

`ELSEIF case_version__v.report_type__v.e2B_code__v = '2' AND study_type__v.e2b_code__v = '1'`

`THEN 'Interventional'`

`ELSEIF case_version__v.report_type__v.e2B_code__v  = '2' AND COALESCE(study_type__v.e2b_code__v,'') NOT IN ('1,'2','3','4','5','6') AND report_type__v.literature__v != Yes`

`THEN 'Interventional'`

`ELSE 'Non-Interventional'`

<tr>
<td markdown="span">5
<td markdown="span">Reporter Country
<td markdown="block">

Vault maps the _Reporter Country_ from the _Case_. If this field is blank, Vault displays `-`.

`case_version__v.reporter_country__v.name__v`

<tr>
<td markdown="span">6
<td markdown="span">Event Country
<td markdown="block">

Vault maps the _Event Country_ from the _Case Adverse Event_.  If this field is blank, Vault displays `-`.

`case_adverse_event__v.event_country__v.name__v`

<tr>
<td markdown="span">7
<td markdown="span">Product Name
<td markdown="block">

Vault maps the _Product_ name from _Case Product_. If the _Product_ is blinded, Vault displays `Blinded`. Otherwise, displays `-` if blank.

`case_product__v.product_name__v`

<tr>
<td markdown="span">8
<td markdown="span">SOC
<td markdown="block">

Vault maps the _MedDRA System Organ Class (SOC)_ on the _Case Adverse Event_. If this field is blank, Vault displays `-`.

`case_adverse_event__v.event_meddra__v.soc_term__v`

<tr>
<td markdown="span">9
<td markdown="span">Preferred Term
<td markdown="block">

Vault maps the _MedDRA Preferred Term (PT)_ on the _Case Adverse Event_.  If this field is blank, Vault displays `-`.

`case_adverse_event__v.event_meddra__v.pt_term__v`

<tr>
<td markdown="span">10
<td markdown="span">Serious (Case Level)
<td markdown="block">

Vault maps the _Serious_ value on the _Case_.

`case_version__v.serious__v`

<tr>
<td markdown="span">11
<td markdown="span">Seriousness
<td markdown="block">

Vault maps the _Seriousness_ value on the _Case Adverse Event_. If this field is blank, Vault displays `-`.

`case_adverse_event__v.seriousness__v`

<tr>
<td markdown="span">12
<td markdown="span">Relatedness
<td markdown="block">

Whether the _Case Adverse Event_ is related to the _Product_, based on DSUR relatedness logic applied to the _Case Assessments_. If no assessment is available, Vault assumes the event is related.

<tr>
<td markdown="span">13
<td markdown="span">Case Expectedness
<td markdown="block">

Vault maps the _Expected_ value on the _Case Assessment_ for the _Case Adverse Event_.

`case_assessment__v.expectedness__v`

<tr>
<td markdown="span">14
<td markdown="span">Lifecycle State
<td markdown="block">

Vault maps the _Lifecycle State_ on the _Case_.

`case_version__v.state__v`

<tr>
<td markdown="span">15
<td markdown="span">Invalid Reason
<td markdown="block">

Vault maps the _Invalid Reason_ on the _Case_. If this field is blank, Vault displays `-`.

`case_version__v.age_normalized_year__v`

<tr>
<td markdown="span">16
<td markdown="span">Age (years)
<td markdown="block">

Vault maps the _Age Normalized Years_ value on the _Case_. If this field is blank, Vault displays `-`.

`case_version__v.age_normalized_year__v`

<tr>
<td markdown="span">17
<td markdown="span">Pregnancy Status
<td markdown="block">

 Vault maps the _Pregnancy_ value on the _Case_.

`case_version__v.pregnancy_case__v`

[1]: #create
[2]: #fields
[3]: #reporting-periods
[4]: #generate
[5]: #inclusion-criteria
[6]: #filter-case-by

[101]: #summary-tab-events-period-product
[102]: #summary-tab-events-expectedness-product
[103]: #summary-tab-events-case-category-product
[104]: #summary-tab-events-seriousness-product
[105]: #summary-tab-events-relatedness-product
[106]: #interval-line-listing-events